India gives conditional market nod for Covishield and Covaxin
People will be able to buy Covishield and Covaxin from hospitals and clinics and the vaccination data have to be updated on Co-Win
Covaxin and Covishield will now be available in the regular market in India as the Drug Controller General of India has given conditional market approval to these two Covid vaccines on Thursday.
The subject expert committee of the Central Drug Standard Control Organisation has earlier recommended granting regular market approval to these Covid-19 vaccines for the adult population, subject to certain conditions. Market approval, however, does not mean that the vaccines will be available in medical shops. People will have to buy Covishield and Covaxin from hospitals and clinics.
Vaccination data has to be submitted to DCGI every six months. Data will have t to be updated on CoWIN app also.
Earlier, it was reported that the Centre was planning to cap the price of the vaccines at ₹275 per dose.
What does market approval mean? What are the conditions
The approval has been granted under the New Drugs and Clinical Trials Rules, 2019.
The firms, in this case, Bharat Biotech (Covaxin) and Serum Institute of India (Covishield), shall submit data of ongoing clinical trials
All vaccination data will be recorded on the CoWIN platform.
The approval is only for adult population.
Adverse events following immunisation will continue to be monitored as part of the conditions.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on 25 October seeking regular market authorisation for Covishield. The DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.
In an application sent to the DCGI, V Krishna Mohan, whole-time director at the Hyderabad-based Bharat Biotech, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on 3 January.
